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The “high-risk” patient

A "high risk" patient with legal addictions to junk food and tobacco.
She would be an excellent candidate for a trial of a drug to "treat" the symptoms, like "cholesterol", of a self-destructive lifestyle. Such people are beloved of drug dealers and trialist doctors on their payrolls because they are "high risk" and have high rates of "events" (i.e. artery bypass, heart attack and death) allowing investigators to publish papers faster and drug dealers to sell more drugs. Thus, all testing of drugs for lifestyle diseases necessitates conflict of interest. To insist that such people change their habits first would reduce "events", most of which are non-fatal, and prolong trials for so long that the high-paid "trialists" would die of old age before enough "events" had been registered to be statistcally significant. So NO trial of drugs for diseases of lifestyle has ever made a serious attempt to change lifestyles before trying drugs. All such trials were and are, therefore, UNETHICAL. Reports of the results of such trials should be retracted by the journals involved and the results should be ignored by all doctors. All such ongoing trials should be halted immediately.

Posts Tagged ‘alberto lorenzatti’

An excellent article by André Picard in today’s Globe and Mail, the only story on JUPITER I have seen in the lay press that reveals the massive fraud behind the reporting of this “study”.

JUPITER is aptly named. It’s gigantic. Probably the largest, most expensive drug trial in history. When one looks below the surface of the publication in the NEJM, the results are about as exciting as the Jovian composition. A lot of gas. I would conservatively estimate that this “study” cost at least $500 million. But if you are AstraZeneca and stand to sell $many billions worth of Crestor because of this paper that’s small change. And junk food addicts, who comprise most of the subjects of JUPITER have one more excuse, however deceptive, to continue their self-destructive habits.

Here is my opinion posted in the NEJM blog on the paper.

A more detailed analysis of the marketing driven deception and lack of professionalism in the paper by Sandy Szwarc.

Another perspective by John McDougall similar to mine on the big lie behind the claim that many “healthy” people need Crestor..

When all of these criticisms are considered it turns out that JUPITER is nothing more than a thinly disguised infomercial for Crestor and should never have been published in a presumably high quality journal like the NEJM. But in being able to make this paper freely available on the web (and not wait 6 months like other papers) the NEJM must have received a large payment from AstraZeneca.

Non-blinded statin trials like JUPITER, have the potential for bias in subjective outcomes like the decision to do an angioplasty or coronary bypass, outcomes that constitute the vast majority of the combined endpoint. Also, it is quite likely that when the JUPITER subjects knew that their blood LDL was low because they were taking Crestor they had less incentive to change self-destructive lifestyles. That is probably why the group treated with Crestor had significantly more diabetes. In light of the JUPITER trial the Therapeutics Initiatives group at the University of British Columbia has updated their recommendations for use of statins in primary prevention, which would include people like those entered into the JUPITER trial, and concluded that “statins do not have a proven net health benefit in primary prevention populations and thus when used in that setting do not represent good use of scarce health care resources.”

What typical JUPITER subjects would look like. These are "apparently healthy" people? Is it not unethical to prescribe drugs to these people to "treat" the symptoms of their self-destructive lifestyles?

Nowhere in the JUPITER paper will you see it mentioned that CRP can be markedly reduced with cost-free lifestyle change alone, no statins, as shown in this paper in the Journal of Applied Physiology in 2006, results of which are summarized below. The subjects in the JAP paper were just the same as in the JUPITER study, obese people, many with metabolic syndrome but the authors did not call them “apparently healthy”. They had nothing to sell.

The New York Times article summarized the exciting news in a front-page story saying that “millions more people could benefit from taking the cholesterol-lowering drugs known as statins.”

That’s big medical/business news, because statins are already the bestselling drugs in the world, with sales in excess of $20-billion (U.S.).

Quoting some of the world’s top heart researchers, media reports touted the importance of a blood test for C-reactive protein. That’s because those benefiting from statins had high levels of CRP (a marker for inflammation) rather than high levels of LDL cholesterol, which is usually the criterion for statin prescription.

The news stories were based on research published last week in the prestigious New England Journal of Medicine and presented, with much fanfare, at the annual convention of the American Heart Association.

Like much reporting on medical research (and drug research in particular), however, there is more (or, more accurately, less) to these stories than meets the eye.

The principal finding in this study was that participants who took a statin pill recorded a 50-per-cent reduction in the risk of heart attack, stroke, surgery and death compared with those who took a placebo (a sugar pill).

Who wouldn’t be wowed by those numbers? Who wouldn’t want that miracle drug?

But the benefits are relative risk reductions.

When you look at the raw data in the study, they reveal that 0.9 per cent of statin users had cardiovascular problems. By comparison, 1.8 per cent of those taking a placebo had heart problems.

There were 17,802 participants in the study, yet there were only 83 cardiac events among statin users, compared with 157 in the placebo group. That’s 50 per cent fewer.

Are those really “dramatic” findings? Do statins really make heart attack risk “plummet”?

According to a cautionary editorial in the New England Journal of Medicine (which received virtually no mention in news reports), 120 people in this study needed to be treated with a statin for two years to see a benefit in one person.

That’s a lot of people taking a pricey drug ($3 Canadian a day) for no benefit – not to mention that there are risks.

While researchers (and journalists who report on studies) love to highlight benefits of drugs, they too often gloss over risks.

Like all drugs, statins have side effects. The drug used in the study, rosuvastatin (brand name Crestor), has been associated with muscle deterioration and kidney problems.

In the study, those taking statins had a higher risk of developing Type 2 diabetes – 3 per cent compared with 2.4 per cent of those taking a placebo. That’s a 25 per cent higher relative risk among people with very little heart disease to begin with.

As noted earlier, researchers (and news stories) suggested that, based on the findings, the number of patients taking statins could and should expand dramatically.

But is that really what the research tells us, even in its most optimistic interpretation?

The study involved exclusively men older than 50 and women older than 60 who did not have high cholesterol or histories of heart disease or inflammatory illness. All the people in the study needed to have low cholesterol and high CRP.

Initially, researchers recruited 90,000 people in those age groups, but more than 80 per cent of them were deemed ineligible. This is a very select population.

To say, by extrapolation, that these “dramatic” (read: modest) benefits apply to the general population is erroneous.

Similarly, while it is true that about half of all heart attacks and strokes occur in people whose cholesterol is not considered high, does that mean everyone should get a blood test to measure levels of C-reactive protein? Hardly.

Yes, there is more heart disease among people with high levels of CRP, but the jury is still out on what this means.

Some scientists believe that because CRP – secreted in response to inflammation – is present in plaque, it increases the risk that the plaque will burst, leading to blood clots that cause heart attacks. But other researchers think that CRP levels are, at best, a telltale sign of heart disease, a bit like grey hairs are a sign of aging – not its cause.

The CRP test is expensive at almost $50. And it’s worth noting that one of the principal authors of the new research holds the patent on the test and makes money every time it is used.

When you cut through all the hype and the self-interest, what we know is this: Statins reduce levels of [LDL] cholesterol. This is beneficial to people who have had a heart attack or other serious heart problems.

But for otherwise healthy people, high CRP levels or not, the potential benefits of taking statins are marginal, and the risks are not insignificant.